Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons

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Congress called on the National Academies to convene a committee to examine the real and perceived risks of liability arising from research conducted with pregnant and lactating women. The resulting report, Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks, explores and finds limited evidence of legal liability for inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability. The committee also makes recommendations that could lead to a more robust evidence base about the safety and efficacy of medications for pregnant and lactating women that would facilitate more informed decision making regarding care while mitigating liability.

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306 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-71688-8
ISBN Ebook: 0-309-71689-6
DOI: https://doi.org/10.17226/27595

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National Academies of Sciences, Engineering, and Medicine. 2024. Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks. Washington, DC: The National Academies Press.

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Pregnant and lactating persons are frequently excluded from clinical research, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing or newborn baby. The National Academies Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a workshop in March 2023 as part of a consensus study to discuss how institutions and organizations make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in clinical research, and the role of real and perceived liability considerations, health equity, risk management, and trial insurance in those decisions. The workshop reviewed existing approaches to manage and mitigate risks relevant to the inclusion of pregnant and lactating persons in clinical research. This Proceedings of a Workshop-in Brief summarizes the discussions held during the workshop.

Publication information

11 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-70624-6
DOI: https://doi.org/10.17226/27142

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2023. Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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Infographic: Factors That Dissuade Sponsors and Investigators from Including Pregnant and Lactating Women in Research

This infographic outlines dissuasive factors for including pregnant and lactating women in clinical research.

Consensus Study Highlights

This interactive resource presents key findings and recommendations from the report, video interviews with committee members, related workshop materials, and more.

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks

In this video, report authoring committee members discuss the importance of this study, lessons learned from the past, and what is needed to enact change.

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Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons

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Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons

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Featured publication

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks

Publications

Policy Brief

Infographic

Highlights